MAUDE Adverse Event Report: MICROVENTION, INC. WEB SL; INTRASACCULAR FLOW DISRUPTION DEVICE

Model Number	W2-9-4-MVI-3
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the web was prepped on the back table, pulled back into the sheath to introduce saline.Then pushed out slowly into a bowl of saline and checked for bubbles, then re-sheathed.The continuity test was performed on the web and passed as a green light appeared.The web was backflushed and then introduced into the via 27 and pushed smoothly in the microcatheter.The vertebral artery had moderate tortuosity, and a kink was created in the pusher wire while advancing, double checked with the detacher, a green light still appeared, and the detachment button was not pushed.Advanced the web through via 27.Upon first deployment of the web, the pusher wire was pulled back to try to manipulate the device and the web detached from pusher wire.Placed a stent to keep right pca open.Patient condition/outcome, stable, neuro status baseline.Additional clarifying information received indicated, the web detached at the detachment zone as intended.It just detached without the controller before we were ready to detach.It detached in a good position but not in the intended position and remains implanted.The physician wanted to do some manipulation to possibly improve the position of the device.The patient recovered well with no deficits and was discharged the next day.
Additional Manufacturer Narrative
A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.Investigation conclusion: the physical device was not available for evaluation to investigate if a condition existed that would have contributed to the reported event.Supplemental imaging was also unavailable for review; without imaging, the investigation cannot verify the event occurred as described, nor could the investigation further examine the cause of the reported event.This information may be updated if additional information is provided at a later date.

• Brand Name: WEB SL
• Common Device Name: INTRASACCULAR FLOW DISRUPTION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 23601376
• Report Number: 2032493-2025-90664
• Device Sequence Number: 9849107
• Product Code: OPR
• UDI-Device Identifier: 00842429107195
• UDI-Public: 00842429107195
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P170032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: W2-9-4-MVI-3
• Device Lot Number: 0000770505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STENT; VIA 27 MICROCATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female